Tests datopotamab deruxtecan with or without durvalumab in advanced triple-negative breast cancer
Tests two treatment combinations against chemotherapy in adults with advanced triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Key facts
- Where
- Bergamo, Empoli, Milan, Naples, Padova, Reggio Emilia, Rome, and Rozzano, ItalySee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with triple-negative breast cancer that is PD-L1 positive. The cancer must have come back and cannot be removed by surgery, or have spread. They must not have had treatment for it yet.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Triple-negative breast cancer that has come back locally and cannot be operated on, or has spread (metastatic). Disease must be measurable (RECIST 1.1). ECOG PS 0 or 1.
- Earlier treatment
- No earlier chemotherapy or other systemic anti-cancer treatment for spread or inoperable returned breast cancer. After treatment for stage I-III breast cancer, at least 6 months must have passed before the cancer came back. No earlier ADC treatment with a topoisomerase I chemotherapy drug and no earlier TROP2-targeted therapy.
- Biomarker or test result
- PD-L1 positive tumour (CPS ≥ 10) on the 22C3 test done by the sponsor's central laboratory. A tumour sample must be provided.
Main reasons for not taking part
- Active or past autoimmune or inflammatory disease
- Clinically significant corneal disease
- Past or current lung inflammation (ILD/pneumonitis) that needed steroids
- Active brain metastases or spinal cord compression
- Currently pregnant or breastfeeding, or planning to become pregnant
Read by machine on 9 November 2026.
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda USL Toscana CentroEmpoli, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2023-503675-24-00
- Record updated
- 24 September 2026
- Original description
To demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBCRead full original descriptionShow less
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
To demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC
Inclusion: Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the the ASCO-CAP guidelines; ECOG PS 0 or 1; Participants are expected to provide a FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour (either de novo metastatic or recurrent metastatic, excluding bone metastases). Alternatively, an archival FFPE tumour sample can be submitted. This archival sample may come from early-stage TNBC; however, it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start); PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory; No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer. Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented inoperable local recurrence or distant recurrence; Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin); Measurable disease as per RECIST 1.1; Adequate bone marrow reserve and organ function; Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.
Exclusion: As judged by the investigator, severe or uncontrolled systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing or active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation, or psychological conditions; Active or prior documented autoimmune or inflammatory disorders; Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy; Any concurrent anti-cancer treatment; History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence; Neoplastic spinal cord compression or active brain metastases, leptomeningeal carcinomatosis or history of leptomeningeal carcinomatosis. Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy; Clinically significant corneal disease; Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd; Uncontrolled infection requiring IV antibiotics, antivirals or antifungals; Active or uncontrolled hepatitis B or C virus infection; Known HIV infection that is not well controlled; Uncontrolled or significant cardiac disease; History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant; Clinically severe pulmonary function compromise.